Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

NCT ID: NCT05401877

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-01

Brief Summary

Breast cancer patients who had undergone surgery, chemotherapy and radiotherapy suffered from complications, including shoulder stiffness, lymphedema and scar contracture. These symptoms impaired one's ADL function. Rehabilitation may relieved symptoms. However, it is difficult to estimate how long one should receive rehabilitation. The study is trying to establish a machine-learning based model in order to predict the period of rehabilitation.

Detailed Description

Breast cancer survivors suffered from complications after surgery, chemotherapy and radiotherapy. These complications include shoulder stiffness, upper limb lymphedema and scar contracture, which altogether impaired one's ADL function. Rehabilitation had been approved to relieved these symptoms effectively. However, many factor may interfere the patient's participation of rehabilitation, making it difficult to estimate how long one should receive rehabilitation. In Taiwan, National Health Insurance provides affordable, accessible and unlimited health care and medical service for all citizens, eliminating many social-economic barriers. Thus we are trying to establish a machine-learning based model in order to predict the period of rehabilitation.

Our study is a retrospective case-control study. The objectives are breast cancer survivors who attended post-surgery rehabilitation at least once for complications. The following data are collected from e-HIS system:

1. Patient characteristic: age, unilateral or bilateral cancer.

2. Surgery type: total, partial or simple mastectomy.

3. Lymphatic surgery: ALND and SLNB

4. Other surgical procedure: breast reconstruction, flap surgery.

5. Combined therapy: chemotherapy, radiotherapy or hormone therapy.

6. Complications: shoulder stiffness, lymphedema, scar contracture (ex., Axillary web syndrome), neurological deficit.

7. The first between operation and first time of rehabilitation.

The primary outcome is the total rehabilitation time, which will be divided as short term (less than 360 min) and long time (more than 360 min).

The data will be processed using WEKA and machine learning algorithms, including Logistic regression, supportive vector machine, K-nearest neighbors, decision tree and random forest.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

short term rehabilitation

breast cancer survivors that recieved post-OP rehabilitation for equal or less than 300 minutes totally.

therapies for breast cancer

Intervention Type: PROCEDURE

the type of tumor removal surgery, combined therapy

long term rehabilitation

breast cancer survivors that recieved post-OP rehabilitation for more than 300 minutes totally.

therapies for breast cancer

Intervention Type: PROCEDURE

the type of tumor removal surgery, combined therapy

Interventions

therapies for breast cancer

the type of tumor removal surgery, combined therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients who received operation for breast cancer
• attended rehabilitation at least once for breast cancer related complications

Exclusion Criteria

• patients who received rehabilitation for other reasons rather than surgical complications
• patients who are transfered to other hospital for rehabilitation

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchun Lee, MD

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Locations

Department of Physical Medicine and Rehabilitation

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

CE21096B

Identifier Type: -

Identifier Source: org_study_id